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Saturday, February 12, 2005

FDA in More Trouble with GOP Senator

Finance Chairman Chuck Grassley (R-IA), who oversees Medicare, came out with news this week that the FDA has seriously dropped the ball in protecting Americans from the drug Adderall. Now, as The New York Times' Gardiner Harris reports, Grassley is stepping up the heat on the agency.

The tension and intrigue surrounding a crucial federal drug advisory committee meeting next week, already high, reached a boil on Friday when Senator Charles E. Grassley charged that top federal drug regulators intended to suppress an important study.

The panel has been convened to discuss whether Celebrex and Bextra, heavily selling arthritis pills from Pfizer, hurt the heart and are worth their potential risks. But top officials of the Food and Drug Administration have forbidden Dr. David Graham, a drug-safety officer at the agency, to discuss before the panel a large study of that very question, said Dr. Gurkirpal Singh of Stanford University School of Medicine, Dr. Graham's co-author.

"We have significant new information that will alter the thinking about these drugs," Dr. Singh said. "I don't understand why they won't let us present this information."

Mr. Grassley, an Iowa Republican, wrote a letter Friday to the agency's acting commissioner, Dr. Lester Crawford, demanding to know by Monday the reason for the agency's decision.
As I've said before, it's time for Bush's FDA to spend a little less time trying to ensure the profits of the pharmaceutical industry and a little more time trying to keep the American people safe.
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